UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to |
Commission File Number:
(Exact name of Registrant as specified in its Charter)
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(State or other jurisdiction of incorporation or organization) |
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(I.R.S. Employer Identification No.) |
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(Address of principal executive offices) |
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(Zip Code) |
Registrant’s telephone number, including area code: (
Securities registered pursuant to Section 12(b) of the Act:
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Title of each class |
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Trading Symbol(s) |
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Name of each exchange on which registered |
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The Nasdaq Stock Market LLC (The Nasdaq Global Select Market) |
Indicate by check mark if the Registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐
Indicate by check mark if the Registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes ☐
Indicate by check mark whether the Registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
Indicate by check mark whether the Registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the Registrant was required to submit such files).
Indicate by check mark whether the Registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer |
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☐ |
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Accelerated filer |
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☐ |
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☒ |
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Smaller reporting company |
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Emerging growth company |
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If an emerging growth company, indicate by check mark if the Registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the Registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes
The aggregate market value of the voting and non-voting common equity held by non-affiliates of the Registrant, based on the closing price of the shares of common stock on The Nasdaq Stock Market on June 30, 2020 (the last day of the Registrant’s most recently completed second fiscal quarter) was approximately $
The number of shares of Registrant’s Common Stock outstanding as of February 28, 2021 was
Portions of the Registrant’s Definitive Proxy Statement relating to the Registrant’s Annual Meeting of Shareholders are incorporated by reference into Part III of this Annual Report on Form 10-K where indicated. Such Definitive Proxy Statement will be filed with the Securities and Exchange Commission within 120 days after the end of the Registrant’s 2020 fiscal year ended December 31, 2020.
Table of Contents
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Page |
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PART I |
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Item 1. |
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2 |
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Item 1A. |
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50 |
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Item 1B. |
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100 |
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Item 2. |
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100 |
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Item 3. |
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100 |
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Item 4. |
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100 |
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PART II |
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Item 5. |
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101 |
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Item 6. |
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103 |
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Item 7. |
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104 |
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Item 7A. |
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114 |
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Item 8. |
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115 |
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Item 9. |
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134 |
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Item 9A. |
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134 |
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Item 9B. |
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134 |
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PART III |
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Item 10. |
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135 |
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Item 11. |
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135 |
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Item 12. |
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135 |
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Item 13. |
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135 |
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Item 14. |
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135 |
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PART IV |
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Item 15. |
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136 |
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Item 16 |
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136 |
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Annual Report on Form 10-K contains forward-looking statements. All statements other than statements of historical facts contained in this Annual Report on Form10-K, including statements regarding our future results of operations and financial position, business strategy, development plans, planned preclinical studies and clinical trials, future results of clinical trials, expected research and development costs, regulatory strategy, timing and likelihood of success, as well as plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. Forward-looking statements contained in this Annual Report on Form 10-K include, but are not limited to, statements about:
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the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; |
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the timing, progress and results of preclinical studies and clinical trials for ORIC-101, ORIC-533, ORIC-944, ORIC-114 and other product candidates we may develop, including statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, and our research and development programs; |
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the timing, scope and likelihood of regulatory filings and approvals, including timing of Investigational New Drug, or IND, or Clinical Trial Application, or CTA, applications and final Food and Drug Administration, or FDA, approval of ORIC-101, ORIC-533, ORIC-944, ORIC-114 and any other future product candidates; |
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the timing, scope or likelihood of foreign regulatory filings and approvals; |
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our ability to develop and advance our current product candidates and programs into, and successfully complete, clinical studies; |
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our manufacturing, commercialization, and marketing capabilities and strategy; |
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our plans relating to commercializing our product candidates, if approved, including the geographic areas of focus and sales strategy; |
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the need to hire additional personnel and our ability to attract and retain such personnel; |
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our expectations regarding the impact of the COVID-19 pandemic on our business; |
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the size of the market opportunity for our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting; |
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our expectations regarding the approval and use of our product candidates in combination with other drugs; |
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our competitive position and the success of competing therapies that are or may become available; |
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our estimates of the number of patients that we will enroll in our clinical trials; |
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the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; |